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Name:Ambi Essentials
Manufacturer:Johnson & Johnson Consumer Products Co., Division Of Johnson & Johnson Consumer Companies, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


AMBI® ESSENTIALS DAILY MOISTURIZER SPF 15 PROTECTION

AMBI ESSENTIALS - avobenzone, octisalate, octocrylene and oxybenzone lotion 
Johnson & Johnson Consumer Products Co., Division of Johnson & Johnson Consumer Companies, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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AMBI® ESSENTIALS DAILY MOISTURIZER SPF 15 PROTECTION

Drug Facts

Active Ingredients Purpose
Avobenzone 3% Sunscreen
Octisalate 5% Sunscreen
Octocrylene 1.7% Sunscreen
Oxybenzone 3% Sunscreen

Uses

  • Helps prevent sunburn
  • Higher SPF gives more sunburn protection
  • Provides moderate protection against sunburn

Warnings

For external use only.

When using this product

  • Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

  • Rash or irritation develops and lasts.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply liberally before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.

Other Information

Sun Alert

Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.

Inactive Ingredients

Water, C12-15 Alkyl Benzoate, Dimethicone, Diethylhexyl 2,6-Naphthalate, Glycerin, Arachidyl Alcohol, Phenyl Trimethicone, Sodium Polyacrylate, Silica, PCA Dimethicone, Cetearyl Alcohol, Phenoxyethanol, Methyl Methacrylate Crosspolymer, Behenyl Alcohol, Aluminum Starch Octenylsuccinate, Steareth-2, Betaine, Fragrance, Arachidyl Glucoside, Methylparaben, Steareth-21, Disodium EDTA, Hydroxypropyl Methylcellulose, Cetearyl Glucoside, Sodium PCA, Propylparaben, Benzalkonium Chloride, Sorbitol, Ethylparaben, Boron Nitride, Serine, Iodopropynyl Butylcarbamate, Glycine, Glutamic Acid, Alanine, Arginine, Lysine, Threonine, Proline

Questions?

Call 1-888-TRY-AMBI or visit www.ambiflawlessskin.com

PRINCIPAL DISPLAY PANEL - 59 mL Label

NEW!

AMBI.

ESSENTIALS
Daily Moisturizer

SPF 15 PROTECTION

Deeply nourishes without
heavy ingredients

Light, oil-free formula

Dermatologist tested

2 FL. Oz. (59mL)

Principal Display Panel - 59 mL Label

AMBI ESSENTIALS 
avobenzone, octisalate, octocrylene and oxybenzone lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58232-0504
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Avobenzone (Avobenzone) Avobenzone 30 mg  in 59 mL
Octisalate (Octisalate) Octisalate 50 mg  in 59 mL
Octocrylene (Octocrylene) Octocrylene 17 mg  in 59 mL
Oxybenzone (Oxybenzone) Oxybenzone 30 mg  in 59 mL
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58232-0504-1 59 mL in 1 TUBE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 01/28/2010

Labeler - Johnson & Johnson Consumer Products Co., Division of Johnson & Johnson Consumer Companies, Inc. (830803164)

Revised: 01/2010 Johnson & Johnson Consumer Products Co., Division of Johnson & Johnson Consumer Companies, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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